{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:43:10Z","timestamp":1787010190448,"version":"build-2736575974"},"reference-count":30,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2015,7,1]],"date-time":"2015-07-01T00:00:00Z","timestamp":1435708800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1\u2010R03\u2010DK068148\u201301"],"award-info":[{"award-number":["1\u2010R03\u2010DK068148\u201301"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. pediatr. gastroenterol. nutr."],"published-print":{"date-parts":[[2015,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To evaluate safety, tolerability, and symptom improvement with once\u2010daily esomeprazole in children with endoscopically proven gastroesophageal reflux disease (GERD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods:<\/jats:title>\n                    <jats:p>In this 8\u2010week, multicenter, randomized, uncontrolled, double\u2010blind study, children ages 1 to 11 years were stratified by weight to receive esomeprazole 5 or 10 mg (children &lt; 20 kg) or 10 or 20 mg (children \u2265 20 kg) once daily. Safety and tolerability was assessed by evaluating adverse events (AEs; both treatment\u2010 and non\u2010treatment\u2010related AEs) and changes from baseline in medical history, physical examinations, and clinical laboratory tests. Investigators scored symptom severity every 2 weeks using the Physician's Global Assessment (PGA). Patients' parents rated GERD symptoms of heartburn, acid regurgitation, and epigastric pain (none to severe, 0\u20133) at baseline (based on past 72 hours) and daily (from past 24 hours).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Of 109 patients randomized, 108 had safety data. AEs were experienced by 68.0% and 65.2% of children &lt;20 kg receiving esomeprazole 5 and 10 mg, respectively, and 83.9% and 82.8% of children \u226520 kg receiving esomeprazole 10 and 20 mg, respectively, regardless of causality. Overall, only 9.3% of patients reported 13 treatment\u2010related AEs; the most common were diarrhea (2.8% [3\/108]), headache (1.9% [2\/108]), and somnolence (1.9% [2\/108]). Vomiting, a serious AE in 2 patients, was not judged by the investigator to be related to treatment. At the final visit, PGA scores improved significantly from baseline (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.001). Of 58 patients with moderate to severe baseline PGA symptom scores, 91.4% had lower scores by the final visit. GERD symptom scores were significantly improved from baseline to the final week of the study in all of the treatment groups (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.01)\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In children ages 1 to 11 years with endoscopically proven GERD, esomeprazole (at daily doses of 5, 10, or 20 mg) was generally well tolerated. The frequency and severity of GERD\u2010related symptoms were significantly reduced during the active treatment period.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1097\/mpg.0b013e318176b2cb","type":"journal-article","created":{"date-parts":[[2010,2,25]],"date-time":"2010-02-25T01:42:41Z","timestamp":1267062161000},"source":"Crossref","is-referenced-by-count":27,"title":["Safety and Tolerability of Esomeprazole in Children With Gastroesophageal Reflux Disease"],"prefix":"10.1002","volume":"60","author":[{"given":"Mark A.","family":"Gilger","sequence":"first","affiliation":[{"name":"Baylor College of Medicine Houston TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasundhara","family":"Tolia","sequence":"additional","affiliation":[{"name":"Wayne State University Detroit MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvan","family":"Vandenplas","sequence":"additional","affiliation":[{"name":"Vrije Universiteit Brussels Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nader N.","family":"Youssef","sequence":"additional","affiliation":[{"name":"Goryeb Children's Hospital at Atlantic Health Morristown NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry","family":"Traxler","sequence":"additional","affiliation":[{"name":"AstraZeneca LP Wilmington DE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Illueca","sequence":"additional","affiliation":[{"name":"AstraZeneca LP Wilmington DE"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,7]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/00128072-200204100-00004"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1536-4801.2001.tb07189.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.154.2.150"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2006.00442.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2004.30098.x"},{"key":"e_1_2_10_7_1","first-page":"334","article-title":"Childhood gastroesophageal reflux symtpoms in adult patients","volume":"35","author":"Waring JP","year":"2002","journal-title":"J Pediatr Gastroenterol Nutr"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/gast.2001.29545"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2005.41217.x"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2002.05532.x"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2001.03443.x"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2001.03600.x"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2006.09.013"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0b013e318148c17c"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2006.11.012"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2000.00829.x"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5107(04)00691-1"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1536-4801.1996.tb00312.x"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.45.2.172"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2001.01076.x"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1590-8658(00)80326-6"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mpg.0000214160.37574.d3"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1536-4801.2002.tb07944.x"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1536-4801.2002.tb07943.x"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1536-4801.2003.tb08001.x"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1067\/mpd.2000.109607"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1177\/0009922806292792"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2006.08.078"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5107(97)70178-0"},{"key":"e_1_2_10_30_1","unstructured":"National Center for Health Statistics.Clinical Growth Charts.http:\/\/www.cdc.gov\/growthcharts. 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